# K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Dec 1, 2023 after 213 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962616 (1996). 126 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181180: OSSIO™ Pin Product Family, OSSIO, Ltd. (2019) Summary page 7.
- K193660: OSSIOfiber™ Compression Screws, OSSIO, Ltd. (2020) Summary page 7.
- K213596: OSSIOfiber Compression Screw, 3.5mm, OSSIO, Ltd. (2021) Summary page 7.
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm, OSSIO, Ltd. (2022) Summary page 7.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 7.
- K203465: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design, OSSIO, Ltd. (2021) Summary page 7.
- K230750: OSSIOfiber® Cannulated Trimmable Fixation Nail, OSSIO, Ltd. (2023). Cleared while this submission was under review Summary page 7.

## Most influential descendants
- K233198: OSSIOfiber® Threaded Trimmable Fixation Nails (2024), 2 descendants of its own
- K241277: OSSIOfiber® Threaded Trimmable Fixation Nail (2024), 1 descendant of its own
- K254077: OSSIOfiber® Threaded Trimmable Fixation Nail (2026), 0 descendants of its own

## Indications for use
OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. The OSSIO® Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

Source page: https://510kreport.com/device/K231272
Methodology: https://510kreport.com/methodology